Transdermal Rotigotine User Surveillance Study (TRUST)

July 11, 2018 updated by: UCB Pharma

A Naturalistic, Multisite, Observational Study of Rotigotine Transdermal Patch and Other Currently Prescribed Therapies in Patients With Idiopathic Parkinson's Disease

This study will be conducted in an observational multiple-cohort design aimed at acquiring clinical, treatment, health status, and economic data. Patients with Parkinson's disease (PD) will be enrolled.

Study Overview

Status

Completed

Conditions

Detailed Description

All patients attending the physician and fulfilling the eligibility criteria are included.

Study Type

Observational

Enrollment (Actual)

2195

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czechia
      • Chomutov, Czechia
        • 813
      • Hradec Kralove, Czechia
        • 808
      • Hradec Kralove, Czechia
        • 822
      • Litomysl, Czechia
        • 811
      • Ostrava-Poruba, Czechia
        • 803
      • Pardubice, Czechia
        • 809
      • Pisek, Czechia
        • 817
      • Plzen-Lochotin, Czechia
        • 814
      • Praha 1, Czechia
        • 805
      • Praha 10, Czechia
        • 829
      • Praha 4, Czechia
        • 825
      • Praha 5, Czechia
        • 804
      • Rakovnik, Czechia
        • 832
      • Zlin, Czechia
        • 819
  • Denmark
      • Aalborg, Denmark
        • 752
      • Aarhus, Denmark
        • 751
      • Sonderborg, Denmark
        • 750
  • Germany
      • Aalen, Germany
        • 242
      • Achim, Germany
        • 143
      • Alzenau, Germany
        • 240
      • Annaberg-Buchholz, Germany
        • 145
      • Aschaffenburg, Germany
        • 245
      • Augsburg, Germany
        • 185
      • Bad Neustadt, Germany
        • 130
      • Bamberg, Germany
        • 131
      • Berg, Germany
        • 103
      • Berlin, Germany
        • 102
      • Berlin, Germany
        • 110
      • Berlin, Germany
        • 113
      • Berlin, Germany
        • 119
      • Berlin, Germany
        • 142
      • Berlin, Germany
        • 150
      • Berlin, Germany
        • 157
      • Berlin, Germany
        • 163
      • Berlin, Germany
        • 166
      • Berlin, Germany
        • 195
      • Berlin, Germany
        • 198
      • Berlin, Germany
        • 206
      • Berlin, Germany
        • 207
      • Berlin, Germany
        • 224
      • Berlin, Germany
        • 243
      • Bielefeld, Germany
        • 108
      • Bielefield, Germany
        • 127
      • Blankenburg (Harz), Germany
        • 178
      • Bochum, Germany
        • 149
      • Bochum, Germany
        • 151
      • Bochum, Germany
        • 216
      • Brandenburg, Germany
        • 220
      • Butzbach, Germany
        • 236
      • Butzbach, Germany
        • 237
      • Böblingen, Germany
        • 203
      • Dresden, Germany
        • 133
      • Dresden, Germany
        • 199
      • Dresden, Germany
        • 232
      • Duisburg, Germany
        • 219
      • Düsseldorf, Germany
        • 112
      • Düsseldorf, Germany
        • 141
      • Emmendingen, Germany
        • 129
      • Erbach, Germany
        • 162
      • Flensburg, Germany
        • 202
      • Friedberg (Hessen), Germany
        • 156
      • Gera, Germany
        • 247
      • Greifswald, Germany
        • 223
      • Hagen, Germany
        • 249
      • Halle (Saale), Germany
        • 167
      • Hamburg, Germany
        • 121
      • Hamburg, Germany
        • 140
      • Hamburg, Germany
        • 176
      • Hamburg, Germany
        • 217
      • Heidenheim, Germany
        • 241
      • Hemmoor, Germany
        • 138
      • Herborn, Germany
        • 173
      • Jena, Germany
        • 214
      • Jena, Germany
        • 248
      • Jülich, Germany
        • 181
      • Karlstadt, Germany
        • 105
      • Karlstadt, Germany
        • 106
      • Kassel, Germany
        • 244
      • Köln, Germany
        • 124
      • Köln, Germany
        • 153
      • Köln, Germany
        • 179
      • Leutkirch, Germany
        • 175
      • Lutherstadt Eisleben, Germany
        • 152
      • Magdeburg, Germany
        • 230
      • Mannheim, Germany
        • 235
      • München, Germany
        • 148
      • München, Germany
        • 189
      • München, Germany
        • 191
      • Naumburg (Saale), Germany
        • 169
      • Neuburg, Germany
        • 182
      • Oberhausen, Germany
        • 118
      • Oberursel (Taunus), Germany
        • 164
      • Oldenburg, Germany
        • 171
      • Oranienburg, Germany
        • 196
      • Rheda-Wiedenbrück, Germany
        • 114
      • Rottenburg Am Neckar, Germany
        • 188
      • Schriesheim, Germany
        • 187
      • Schwerin, Germany
        • 107
      • Singen, Germany
        • 134
      • Stadtroda, Germany
        • 229
      • Starnberg, Germany
        • 180
      • Stuttgart, Germany
        • 146
      • Stuttgart, Germany
        • 186
      • Stuttgart, Germany
        • 211
      • Tübingen, Germany
        • 226
      • Ulm, Germany
        • 139
      • Unterhaching, Germany
        • 172
      • Westerstede, Germany
        • 239
      • Wiesbaden, Germany
        • 233
      • Wolfach, Germany
        • 122
      • Zwickau, Germany
        • 194
  • Greece
      • Alexandroupoli, Greece
        • 607
      • Athens, Greece
        • 600
      • Athens, Greece
        • 602
      • Athens, Greece
        • 605
      • Athens, Greece
        • 610
      • Chaidari, Greece
        • 608
      • Marousi, Greece
        • 611
      • Melissia, Greece
        • 601
      • Thessaloniki, Greece
        • 604
      • Thessaloniki, Greece
        • 606
  • Italy
      • Acquaviva Delle Fonti, Italy
        • 664
      • Ancona, Italy
        • 654
      • Bari, Italy
        • 665
      • Cagliari, Italy
        • 655
      • Casarano, Italy
        • 666
      • Cassino, Italy
        • 662
      • Ferrara, Italy
        • 653
      • Imperia, Italy
        • 661
      • Lido Di Camaiore, Italy
        • 650
      • Lodi, Italy
        • 663
      • Messina, Italy
        • 658
      • Napoli, Italy
        • 660
      • Pisa, Italy
        • 667
      • Roma, Italy
        • 657
      • San Giovannni Rotondo, Italy
        • 656
      • Torino, Italy
        • 669
  • Mexico
      • Aguascalientes, Mexico
        • 704
      • Guadalajara, Mexico
        • 707
      • Merida, Mexico
        • 703
      • Mexico D.F., Mexico
        • 701
      • Mexico D.F., Mexico
        • 702
      • Monterrey, Mexico
        • 706
      • Morelia Michoacan, Mexico
        • 710
      • San Luis Potosi, Mexico
        • 708
      • Zapopan, Mexico
        • 705
  • Romania
      • Arad, Romania
        • 425
      • Bacau, Romania
        • 406
      • Bacau, Romania
        • 407
      • Bistrita, Romania
        • 417
      • Bucharest, Romania
        • 412
      • Bucharest, Romania
        • 418
      • Bucharest, Romania
        • 423
      • Bucharest, Romania
        • 424
      • Bucharest, Romania
        • 434
      • Bucharest, Romania
        • 436
      • Constanta, Romania
        • 427
      • Craiova, Romania
        • 411
      • Craiova, Romania
        • 433
      • Drobeta Turnu Severin, Romania
        • 404
      • Foscani, Jud. Vrancea, Romania
        • 437
      • Galati, Romania
        • 405
      • Galati, Romania
        • 420
      • Lasi, Romania
        • 403
      • Lasi, Romania
        • 409
      • Medgidia, Romania
        • 415
      • Orastie, Romania
        • 402
      • Pitesti, Romania
        • 401
      • Pitesti, Romania
        • 428
      • Resista, Romania
        • 422
      • Râmnicu Vâlcea, Romania
        • 435
      • Satu Mare, Romania
        • 408
      • Sfantu Gheorghe, Romania
        • 429
      • Sibiu, Romania
        • 413
      • Targoviste, Romania
        • 416
      • Timisoara, Romania
        • 414
      • Timisoara, Romania
        • 421
      • Târgu-Mureş, Romania
        • 432
  • Slovakia
      • Banska Bystrica, Slovakia
        • 521
      • Bratislava, Slovakia
        • 500
      • Bratislava, Slovakia
        • 502
      • Bratislava, Slovakia
        • 507
      • Bratislava, Slovakia
        • 514
      • Dolni Kubin, Slovakia
        • 501
      • Dubnica Nad Vahom, Slovakia
        • 505
      • Krompachy, Slovakia
        • 522
      • Lucenec, Slovakia
        • 520
      • Skalica, Slovakia
        • 508
      • Spisska Nova Ves, Slovakia
        • 503
      • Stara Lubovna, Slovakia
        • 509
      • Trencin, Slovakia
        • 510
      • Vranov, Slovakia
        • 519
      • Zilina, Slovakia
        • 516
      • Zvolen, Slovakia
        • 518
  • Spain
      • Alzira (Valencia), Spain
        • 308
      • Badalona, Spain
        • 320
      • Barcelona, Spain
        • 301
      • Barcelona, Spain
        • 303
      • Barcelona, Spain
        • 305
      • Barcelona, Spain
        • 318
      • Burgos, Spain
        • 315
      • Ciudad Real, Spain
        • 313
      • Madrid, Spain
        • 306
      • Madrid, Spain
        • 307
      • Palma de Mallorca, Spain
        • 314
      • Valencia, Spain
        • 312
  • Switzerland
      • Biel, Switzerland
        • 355
      • Sargans, Switzerland
        • 353
      • St. Gallen, Switzerland
        • 354
      • Tschugg, Switzerland
        • 351
      • Zürich, Switzerland
        • 350

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Primary Care

Description

Inclusion Criteria:

  • Patients with idiopathic early-stage Parkinson's Disease requiring dopaminergic monotherapy (rotigotine, other dopamine agonists or levodopa) at study onset
  • Patients with advanced-stage Parkinson's Disease requiring dopaminergic therapy with levodopa in combination with rotigotine or other dopamine agonists at study onset

Exclusion Criteria:

  • Patients who are unable to comply with study requirements

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Neupro
Neupro at study onset
Dopamine Agonist
Other Dopamine-Agonist at study onset
L-Dopa
Neupro + L-Dopa
Neupro in combination with L-Dopa at study onset
Dopamine Agonist + L-Dopa
Other Dopamine Agonist in combination with L-Dopa at study onset

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part III at Visit 7 (Month 33)
Time Frame: From Baseline to Visit 7 (Month 33)
The Unified Parkinson's disease rating scale (UPDRS) Part III (Motor Examination) contains 31 questions. Each question ranges from 0 (best possible outcome) to 4 (worst outcome). The total score ranges from 0 (best possible outcome) to 124 (worst outcome).
From Baseline to Visit 7 (Month 33)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Question 32 of Part IV at Visit 7 (Month 33)
Time Frame: From Baseline to Visit 7 (Month 33)
The Unified Parkinson's disease rating scale (UPDRS) question 32 of part IV asks. "What Proportion of the waking day are dyskinesias present?" Answers range from 0 (None) to 4 (76-100 % of the day).
From Baseline to Visit 7 (Month 33)
Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Question 33 of Part IV at Visit 7 (Month 33)
Time Frame: From Baseline to Visit 7 (Month 33)
The Unified Parkinson's disease rating scale (UPDRS) Part IV question 33 asks for complications of therapy in the past week, through the question "How disabling are the dyskinesias ? " Answers range from 0 (Not disabling) to 4 (Completely disabling).
From Baseline to Visit 7 (Month 33)
Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Question 39 of Part IV at Visit 7 (Month 33)
Time Frame: 33 months
The Unified Parkinson's disease rating scale (UPDRS) Part IV question 39 asks "What proportion of the waking day is the patient "off", on average?" Answers range from 0 (None) to 4 (76-100 % of the day).
33 months
Change From Baseline in Nocturnal Dystonia Cramp Score (NADCS) at Visit 7 (Month 33)
Time Frame: 33 months

The NADCS assesses sleep-related motor complaints including nocturnal akinesia, dystonia and painful cramps by an ordinal severity scale.

The NADCS total score ranges from 0 (normal) to 4 (maximum severity). NADCS value was missing for one subject at Visit 7.
33 months
Hoehn & Yahr Stage at Visit 7 (Month 33)
Time Frame: 33 months

The Hoehn and Yahr staging of Parkinson's disease in the "on" stage, if applicable, had to be completed by the physician.

Possible staging:

  • 0 No signs of disease
  • 1 Unilateral disease
  • 2 Bilateral disease without impairment of balance
  • 3 Mild to moderate bilateral disease, some postural instability, physically dependent
  • 4 Severe disability, still able to walk or stand unassisted
  • 5 Wheelchair bound or bedridden unless aided
33 months
Reported Adverse Events of Cardiac Valve Fibrosis During the Study (up to 33 Months)
Time Frame: 33 months
The analysis was performed for the non-disjunctive classification into patients at risk to develop an Adverse Event associated with Rotigotine and patients at risk to develop an Adverse Event not associated with Rotigotine.
33 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

UCB Pharma

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2006

Primary Completion (Actual)

April 1, 2014

Study Completion (Actual)

April 1, 2014

Study Registration Dates

First Submitted

January 10, 2008

First Submitted That Met QC Criteria

January 10, 2008

First Posted (Estimate)

January 23, 2008

Study Record Updates

Last Update Posted (Actual)

August 9, 2018

Last Update Submitted That Met QC Criteria

July 11, 2018

Last Verified

July 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SP0854

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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